NCT00674388

Brief Summary

The Study is designed to collect information about adverse events that occur in children undergoing anesthesia in participating hospitals. Demographic information will be collected on all anesthetics. An analysis of each adverse event will be performed and entered into the database. From this information we will devise strategies to prevent these adverse events.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000,000

participants targeted

Target at P75+ for all trials

Timeline
178mo left

Started Feb 2008

Longer than P75 for all trials

Geographic Reach
1 country

37 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Feb 2008Dec 2040

Study Start

First participant enrolled

February 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2008

Completed
27.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2035

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2040

Last Updated

May 21, 2025

Status Verified

May 1, 2025

Enrollment Period

27.8 years

First QC Date

May 5, 2008

Last Update Submit

May 15, 2025

Conditions

Keywords

ChildrenAnesthesiaSurgeryComplication

Outcome Measures

Primary Outcomes (1)

  • number of adverse events

    5 years

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All Children undergoing anesthesia at the participating hospitals

You may qualify if:

  • All children undergoing anesthesia at participating hospitals

You may not qualify if:

  • Patients over 21 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (37)

Phoenix Children's Hospital

Phoenix, Arizona, 85106, United States

RECRUITING

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

RECRUITING

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

Oakland Medical Center

Oakland, California, 94611, United States

RECRUITING

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94304, United States

RECRUITING

Colorado Children's Hospital

Aurora, Colorado, 80045, United States

RECRUITING

Nemours/Alfred I duPont Hospital for Children

Wilmington, Delaware, 19803, United States

RECRUITING

Children's National Health System

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Arnold Palmer Children's Hospital

Orlando, Florida, 32806, United States

RECRUITING

All Children's Hospital

St. Petersburg, Florida, 33701, United States

RECRUITING

Emory Children's Center

Atlanta, Georgia, 30322, United States

RECRUITING

Children's Memorial Hospital

Chicago, Illinois, 60614, United States

RECRUITING

University of Iowa Stead Family Children's Hospital

Iowa City, Iowa, 52242, United States

RECRUITING

Johns Hopkins Childrens Center

Baltimore, Maryland, 21287, United States

RECRUITING

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

RECRUITING

University of Michigan CS Mott Children's Hospital

Ann Arbor, Michigan, 48109, United States

RECRUITING

SSM Cardinal Glennon Health Care System

St Louis, Missouri, 63104, United States

RECRUITING

Children's Hospital and Medical Center

Omaha, Nebraska, 68114, United States

RECRUITING

Womens and Childrens Hospital of Buffalo

Buffalo, New York, 14222, United States

RECRUITING

Morgan Stanley Children's Hospital

New York, New York, 10032, United States

RECRUITING

Children's Hospital at Montefiore

New York, New York, 10467, United States

RECRUITING

Akron Children's Hospital

Akron, Ohio, 44308, United States

RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

Cleveland Clinic Children's Hospital

Cleveland, Ohio, 44195, United States

RECRUITING

Dayton Children's Hospital

Dayton, Ohio, 45404, United States

RECRUITING

Penn State Hershey Children's Hospital

Hershey, Pennsylvania, 17033, United States

RECRUITING

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Pittsburgh Children's Hospital

Pittsburgh, Pennsylvania, 15224, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29412, United States

RECRUITING

LeBonheur Children's Hospital

Memphis, Tennessee, 38103, United States

RECRUITING

St Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

RECRUITING

Monroe Carell Jr Children's Hospital at Venderbilt

Nashville, Tennessee, 37232, United States

RECRUITING

Dell Children's Medical Center of Central Texas

Austin, Texas, 78723, United States

RECRUITING

Children's Medical Center Dallas

Dallas, Texas, 75235, United States

RECRUITING

Cook Children's Health Care System

Fort Worth, Texas, 76104, United States

RECRUITING

Texas Children's Hospital

Houston, Texas, 77030, United States

RECRUITING

Seattle Children's Hospital

Seattle, Washington, 98105, United States

RECRUITING

Study Officials

  • Jayant K Deshpande, MD MPH, MD

    The Society for Pediatric Anesthesia

    STUDY DIRECTOR

Central Study Contacts

Jayant K Deshpande, MD, MPH

CONTACT

Anna Varughese, MD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
2 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Director, Wake up Safe

Study Record Dates

First Submitted

May 5, 2008

First Posted

May 7, 2008

Study Start

February 1, 2008

Primary Completion (Estimated)

December 1, 2035

Study Completion (Estimated)

December 1, 2040

Last Updated

May 21, 2025

Record last verified: 2025-05

Locations